NCT03732560已完成不适用
A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年7月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) from Advanced Diagnosis
研究概览
简要总结
The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older
- •First advanced of diagnosis of metastatic/Stage IV) melanoma
- •Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection)
- •Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017
- •Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
排除标准
- •Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Overall Survival (OS) from Advanced Diagnosis
时间窗: Minimum follow up 1 year
次要结局
- Progression Free Survival (PFS) from Advanced Diagnosis(Minimum follow up 1 year)
- Overall Survival (OS) from 1L Therapy Initiation(Minimum follow up 1 year)
- Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria(Minimum follow up 1 year)
- Time to Best Therapy Response(Minimum follow up 1 year)
- Response Evaluation Criteria in Solid Tumors (RECIST)(Minimum follow up 1 year)
- Incidence of SAE's(Minimum follow up 1 year)
- Progression Free Survival (PFS) from Index Date(Minimum follow up 1 year)
- Objective Response Rate (ORR)(Minimum follow up 1 year)
- Best Therapy Response(Minimum follow up 1 year)
- Time to Loss of Peak Response(Minimum follow up 1 year)
- Incidence of AE's(Minimum follow up 1 year)
研究者
研究点 (1)
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